Biodel discloses accelerated development plan for diabetes drugs

DANBURY, Conn. — A drug maker focused on development and commercialization of diabetes treatments unveiled its accelerating clinical development plans of two drug candidates.

Biodel said BIOD-105 and BIOD-107, known as ultra rapid-acting insulins, are designed to result in more rapid insulin action, compared with currently marketed mealtime insulin analogs.

The company said it is initiating a phase-1 trial in third quarter 2011, which will examine the efficacy of the drugs in Type 1 diabetes patients, and will be followed by a phase-2 trial in fourth quarter 2011 if the initial phase is successful. The phase-2 study is intended to follow the same overall design that would be implemented in phase-3 studies, which would commence in 2012 and include two separate pivotal trials — one in patients with Type 1 diabetes and the other in patients with Type 2 diabetes.

Biodel said it recently received initial guidance from the Food and Drug Administration on the design of two pivotal phase-3 clinical trials. "We have identified two new formulations with commercial target product profiles that appear to be superior to any of our previous ultra rapid-acting human insulin drug candidates," said Errol De Souza, president and CEO of Biodel. "We have accelerated the clinical development program of these formulations and plan to initiate phase-1 clinical testing this month and could initiate phase-3 testing before the end of 2012."

’60 Minutes’ examines counterfeit drug problem

NEW YORK — "Fake drugs are a big threat and an exploding threat," Kumar Kibble, deputy director of Immigration and Customs Enforcement, told the news program "60 Minutes" in a segment that appeared Sunday night.

Kibble, who tracks counterfeit drugs from their source in clandestine labs around the world to the United States, where they’re typically sold online through rogue pharmacy sites, told "60 Minutes" that increasingly, traditional criminal groups, including many once involved in illegal drug trafficking, are shifting operations to take advantage of the low-risk/high-reward economics of the counterfeit drug trade — a $75 billion-a-year industry, according to estimates.

The segment opened with an early morning raid on a Peruvian counterfeit pill operation run out of an indoor market and a shabby one-room, makeshift lab, where knock-off Pfizer products were being crudely manufactured. Peruvian law enforcement was tipped off about the operation by Pfizer’s John Clark, who heads the company’s global security team, which is comprised of former Federal Bureau of Investigation, Homeland Security and Drug Enforcement Administration agents. The group works with local law enforcement to identify and prosecute international drug counterfeiters.

Timing of the segment was impeccable, as the retail pharmacy industry gathered for the annual National Association of Chain Drug Stores Supply Chain and Logistics Conference this week, March 13 to 15, in San Diego. Shutting down the flow of counterfeit drugs into the United States and preserving the integrity of the nation’s drug supply system has long been a focus of pharmacy industry leaders, and the conference this year featured important educational sessions focused on the topic, as well as demonstrations of new technologies and information system-based solutions aimed at protecting the supply chain.

Express Scripts reaches smart-phone users with new app

ST. LOUIS — Patients with smart phones using pharmacy benefits served by Express Scripts can access their accounts through a new application launched Monday, the PBM said.

Members who use the iPhone or Android phones can download the Express Rx app from the Apple App Store or Android Market, respectively. Users of other smart phones, such as BlackBerry devices, can use Express Scripts’ mobile-optimized website at M.ESRX.com. The app and website allow users to order refills, check order status, look up drug information and sign up for home delivery; if phones have GPS, the app will direct them to the closest retail pharmacy in their network.

“The Express Scripts Pharmacy is the most reliable path between our members and their medications, and is the cornerstone of our commitment to deliver better health outcomes and lower costs,” Express Scripts VP Rx distribution Jacob Cedergreen said. “This is another example of how we are constantly innovating and improving the Express Scripts Pharmacy to provide our clients and members the best possible service and convenience.”

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